Metastatic Renal Cell CarcinomaNCT04961320
Occupational Therapy Fatigue Management-Based Intervention for Metastatic Renal Cell Carcinoma
A study testing Occupational Therapy and Questionnaire Administration in people with Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope Medical Center.
Trial summary
This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). Many patients diagnosed with cancer experience cancer-related fatigue. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
- What is being tested?
- Occupational Therapy and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2022to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and over.
- Sufficiently fluent in English.
- Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).
- Evidence of metastatic disease.
- Clinician assessed prognosis of greater than or equal to six months.
- Patients who are undergoing immunotherapy treatment (with a checkpoint inhibitor) for advanced kidney cancer who have grade 1 or 2 fatigue based on physician assessment at the time of study entry.
- Willing and independently able to provide consent.
Who cannot join
None listed.
About this study
Official title: Assessing Efficacy of an Occupational Therapy Fatigue Management-Based Intervention for Patients With Metastatic Renal Cell Carcinoma
This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). Many patients diagnosed with cancer experience cancer-related fatigue. These patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives. Occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs. Fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens. This trial may help patients address and reduce their fatigue.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine if an occupational therapy (OT)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (BFI) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
- To determine if an OT-based intervention can improve pain ratings. II. To determine if an OT-based intervention can improve indices of depression. III. To determine if an OT-based intervention can improve indices of anxiety. IV. To determine if an OT-based intervention can maintain a reduced level of fatigue beyond the period of intervention.
OUTLINE:
Patients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.
- Being tested
- Occupational Therapy, Questionnaire Administration
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational TherapyBehavioural
Also called OT
Participate in OT session
Questionnaire AdministrationOther
Complete questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (OT, questionnaires) | Experimental | Patients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks. Receives: Behavioral: Occupational Therapy; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Inventory Score
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score.
Brief Fatigue Inventory is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes.
Measured: Baseline up to 5 weeks
Secondary outcomes (4)
Pain ratings
Pairwise differences of score will be calculated for the PAIN assessment tools per patient, between baseline and the follow-up time points of 5 and 12 weeks. Descriptive statistics will be used to summarize the change in pain score, (from baseline to 5- and 12- weeks). Plots will be utilized to help visualize the changes in scores over time. The scale for the PAIN tool ranges 0-10, with the higher scores indicating worse outcomes.
Measured: Baseline up to 5 and 12 weeks
Depression
Pairwise differences of score will be calculated for the Depression assessment tool per patient, between baseline and the follow-up time points of 5 and 12 weeks. Descriptive statistics will be used to summarize the change in the PROMIS Depression score, (from baseline to 5- and 12- weeks). Plots will be utilized to help visualize the changes in Depression scores over time. Total score for the PROMIS Depression tool ranges from 8 to 40, with higher scores indicating worse outcomes.
Measured: From baseline to 5 and 12 weeks
Anxiety
Pairwise differences of score will be calculated for the PROMIS Anxiety tool per patient, between baseline and the follow-up time points of 5 and 12 weeks. Descriptive statistics will be used to summarize the change in the anxiety score, indices of anxiety and depression, and fatigue score (from baseline to 5- and 12- weeks). Plots will be utilized to help visualize the changes in anxiety scores over time. The total possible score for the PROMIS for the PROMIS for the PROMIS Anxiety tool ranges from 7 to 35, with higher scores indicating worse outcomes.
Measured: From baseline to 5 and 12 weeks
Fatigue Inventory Score
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score. Fatigue is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes.
Measured: At 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start15 Jul 2022 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Why it stopped: slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sumanta K Pal, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961320
- Sponsor's protocol ID
- 20566
- Other IDs
- NCI-2021-05561, 20566, P30CA033572
- Status last verified
- Jun 2022
- First submitted
- 11 Jun 2021
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Efficacy of an Occupational Therapy Fatigue Management-Based Intervention for Patients With Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT04961320
- Acronym / sponsor ID
- 20566
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Jul 2022 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial studies the effects of occupational therapy fatigue management in patients with renal cell cancer that has spread to other places in the body (metastatic). Many patients diagnosed with cancer experience cancer-related fatigue. These patients that are also on immunotherapy can experience added distressing fatigue that impacts their daily lives. Occupational therapy uses a client-centered and holistic approach to work collaboratively with patients to assess fatigue and develop strategies to manage each individual's specific needs. Fatigue-based management is a fundamental component of occupational therapy rehabilitation regimens. This trial may help patients address and reduce their fatigue.
Detailed description
PRIMARY OBJECTIVE:
- To determine if an occupational therapy (OT)-based intervention can reduce cancer-related fatigue by 10 percent as measured by the brief fatigue inventory (BFI) tool, in patients undergoing immunotherapy for metastatic renal cell carcinoma.
SECONDARY OBJECTIVES:
- To determine if an OT-based intervention can improve pain ratings. II. To determine if an OT-based intervention can improve indices of depression. III. To determine if an OT-based intervention can improve indices of anxiety. IV. To determine if an OT-based intervention can maintain a reduced level of fatigue beyond the period of intervention.
OUTLINE:
Patients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (OT, questionnaires) | Experimental | Behavioral: Occupational Therapy, Other: Questionnaire AdministrationPatients participate in OT sessions weekly for 3 weeks over 30 minutes each. Patients also complete questionnaires to assess anxiety, depression, fatigue and pain at baseline, 5 and 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 and over.
- Sufficiently fluent in English.
- Cytologically or pathologically verified diagnosis of renal cell carcinoma (RCC).
- Evidence of metastatic disease.
- Clinician assessed prognosis of greater than or equal to six months.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occupational TherapyAlso: OTParticipate in OT session | Behavioural | Supportive care (OT, questionnaires) |
| Questionnaire AdministrationComplete questionnaires | Other | Supportive care (OT, questionnaires) |
Primary outcome
Fatigue Inventory Score
Time frame: Baseline up to 5 weeks
Percentage of patients with a 10 percent or greater reduction in brief fatigue inventory score. Brief Fatigue Inventory is scored on an 10 points scale (0 to 10), with higher scores indicating worse outcomes.
4 secondary outcomes
Pain ratings
Time frame: Baseline up to 5 and 12 weeks
Depression
Time frame: From baseline to 5 and 12 weeks
Anxiety
Time frame: From baseline to 5 and 12 weeks
Fatigue Inventory Score
Time frame: At 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sumanta K Pal principal investigator
City of Hope Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy and Questionnaire Administration in people with Metastatic Renal Cell Carcinoma and Stage IV Renal Cell Cancer AJCC v8, run by City of Hope Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Inventory Score (time frame: Baseline up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.